ABRAXANE plus gemcitabine also demonstrated a statistically significant
improvement in key secondary endpoints compared to gemcitabine alone,
including a 31% reduction in the risk of progression or death with a
median progression-free survival (PFS) of 5.5 vs. 3.7 months (HR 0.69,
P=0.000024) and an overall response rate (ORR) of 23% compared to 7%
(response rate ratio of 3.19, p=1.1 x 10-10). Another
endpoint assessed included time to treatment failure, which was
significantly improved with the ABRAXANE combination compared to
gemcitabine alone [(median 5.1 vs. 3.6 months) (HR 0.70, P a dose-limiting toxicity of ABRAXANE
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Monitor for myelotoxicity by performing complete blood cell counts
frequently, including prior to dosing on Day 1 for metastatic breast
cancer (MBC) and Days 1, 8, and 15 for non-small cell lung cancer
(NSCLC)
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Do not administer ABRAXANE to patients with baseline absolute
neutrophil counts (ANC) of less than 1,500 cells/mmsup3/sup
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In the case of severe neutropenia (500 cells/mmsup3/sup for
seven days or more) during a course of ABRAXANE therapy, reduce the
dose of ABRAXANE in subsequent courses in patients with either MBC or
NSCLC
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In patients with MBC, resume treatment with every-3-week cycles of
ABRAXANE after ANC recovers to a level 1,500 cells/mmsup3/sup
and platelets recover to >100,000 cells/mm3
In patients with NSCLC, resume treatment if recommended at permanently
reduced doses for both weekly ABRAXANE and every-3-week carboplatin
after ANC recovers to at least 1,500 cells/mm3 and platelet
count of at least 100,000 cells/mm3 on Day 1 or to an ANC
of at least 500 cells/mm3 and platelet count of at least
50,000 cells/mm3 on Days 8 or 15 of the cycle

Nervous System

Sensory neuropathy is dose- and schedule-dependent
The occurrence of Grade 1 or 2 sensory neuropathy does not generally
require dose modification
If ≥ Grade 3 sensory neuropathy develops, treatment should be withheld
until resolution to Grade 1 or 2 for MBC or until resolution to ≤
Grade1 for NSCLC followed by a dose reduction for all subsequent
courses of ABRAXANE

Hypersensitivity

Severe and sometimes fatal hypersensitivity reactions, including
anaphylactic reactions, have been reported
Patients who experience a severe hypersensitivity reaction to ABRAXANE
should not be re-challenged with this drug

Hepatic Impairment

Because the exposure and toxicity of paclitaxel can be increased with
hepatic impairment, administration of ABRAXANE in patients with
hepatic impairment should be performed with caution
The starting dose should be reduced for patients with moderate or
severe hepatic impairment

Albumin (Human)

ABRAXANE contains albumin (human), a derivative of human blood

Use in Pregnancy: Pregnancy Category D

ABRAXANE can cause fetal harm when administered to a pregnant woman
If this drug is used during pregnancy, or if the patient becomes
pregnant while receiving this drug, the patient should be apprised of
the potential hazard to the fetus
Women of childbearing potential should be advised to avoid becoming
pregnant while receiving ABRAXANE